Data integrity is a major concern for the pharmaceutical industry, as it is essential to ensure that all data collected and used is accurate, reliable and available. It is critical to have comprehensive strategies in place to ensure their data remain secure throughout their entire lifecycle.
A Data Integrity gap assessment needs to be performed in all systems and equipment involved in manufacturing and quality activities, considering their role and their impact in data lifecycle.
I find it useful to count on appropriate and complete checklist for the assessment, including questions as:
- What kind of data are handled by the system? (raw data, metadata, system configuration and parameters, user’s information, audit trail)
- What kind of activities are performed by the system with data? (collect, generate, record, transform, analysis, import/export, storing)
- Does the system keep data or metadata? Are there any measures in place to keep data secured and protected against damage, manipulation or loss?
- Does the system allow user’s management?
- Does the system include an Audit Trail function?
- Has the system been validated? Is validation complete, accurate and up to date?
- Are there SOPs in place for the system’s use, administration, management, and maintenance?
- According to the obtained results, actions to be taken should be defined and implemented to ensure data integrity.
- Do you use checklists for data integrity gap assessment? I do, and I find them very helpful not to forget anything important, and to keep the assessment focused.
- What do you think are the main challenges for this assessment? Have you completed the assessment for all your systems and equipment?
Resource Person: Marta Rodríguez Vélez
